Direct vision cryosurgical probe and methods of use

ABSTRACT

A direct vision cryosurgical and methods of use are described herein where the device may generally comprise an elongated rigid structure with a distal end, a proximal end, and a central lumen. The distal end may comprise a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen. The distal end may also house at least one imaging device configured for distal imaging. A proximal end of the device may comprise a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-ablation probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Continuation of U.S. application Ser. No.15/804,652, filed Nov. 6, 2017, which is a Continuation of U.S.application Ser. No. 14/339,024 filed Jul. 23, 2014, which claimspriority to U.S. Provisional Application Ser. No. 61/858,104 filed Jul.24, 2013, the full disclosures of these applications being incorporatedherein by reference in their entirety for all purposes.

FIELD OF THE INVENTION

The present invention relates to cryosurgical probes and their methodsof use. More particularly, the present invention relates to cryosurgicalprobes which are configured to be advanced into a body lumen whileproviding for direct visualization.

BACKGROUND OF THE INVENTION

Accessing and treating regions within a body lumen such as the nasalcavities are often performed by utilizing a probe which is cooled via achilled fluid, a cryo-fluid such as Nitrous Oxide, or through some othercooling mechanism. The cooled tip can be placed into contact against thetissue region to be treated. However, proper positioning of the coolingprobe relative to the tissue may be difficult to achieve due to a numberof factors such as limited space, lack of visual contact, anatomicalobstructions, etc.

Accordingly, devices and methods which can overcome such obstacles toeffectively treat tissue regions in body lumens through cryo-therapy areneeded.

SUMMARY OF THE INVENTION

It is an object of this invention to provide a surgical system for imageguided cryo-ablation of a discrete anatomical structure within amammalian body, through a surgically created or natural body orifice,for the purpose of diagnosing or treating disease or injury.

In accordance with one aspect of this invention is a surgical devicecomprising an elongated rigid structure with a distal end, a proximalend, and a central lumen; with said distal end comprising a non-coringoptically transparent needle tip with at least one lateral fenestrationin communication with the central lumen, housing at least one imagingdevice configured for distal imaging; said proximal end comprising ahandle with a means for connecting the imaging device(s) to an imagingdisplay(s), and a means for accessing bodily tissue in the vicinity ofthe distal end with a cryo-ablation probe through the central lumen andthe lateral fenestration(s) for diagnostic or therapeutic purposes.

In accordance with another aspect of this invention is a surgical devicecomprising an elongated rigid structure with a distal end, a proximalend, and a central lumen; with said distal end comprising a non-coringoptically transparent needle tip with at least one lateral fenestrationin communication with the central lumen, housing at least one imagingdevice configured for distal imaging; said proximal end comprising ahandle with a means for connecting the imaging device(s) to an imagingdisplay(s), and a means for accessing bodily tissue in the vicinity ofthe distal end with a cryo-surgical probe through the central lumen andthe lateral fenestration(s) for diagnostic or therapeutic purposes,whereby the needle tip is configured for advancement towards a surgicaltarget through a facial boundary between two or more discrete anatomicalstructures in a substantially atraumatic manner, and the imaging deviceis used to guide the advancement of the needle tip.

In accordance with another aspect of this invention is a surgical devicecomprising an elongated rigid structure with a distal end, a proximalend, and a central lumen; with said distal end comprising a non-coringoptically transparent needle tip with at least one lateral fenestrationin communication with the central lumen, housing at least one imagingdevice configured for distal imaging, and further comprising aninflatable structure proximal to the needle tip; said proximal endcomprising a handle with a means for connecting the imaging device(s) toan imaging display(s), and a means for accessing bodily tissue in thevicinity of the distal end with a cryosurgical probe through the centrallumen and the lateral fenestration(s) for diagnostic or therapeuticpurposes, and a means for inflating the inflatable structure, wherebythe needle tip is configured for advancement towards a surgical targetthrough a facial boundary between two or more discrete anatomicalstructures in a substantially atraumatic manner, and the imaging deviceis used to guide the advancement of the needle tip, and the inflatablestructure is configured to further separate the anatomical structure(s)as the needle tip is advanced.

In accordance with another aspect of this invention is a surgical devicecomprising an elongated rigid structure with a distal end, a proximalend, and a central lumen; with said distal end comprising a non-coringoptically transparent needle tip with at least one lateral fenestrationin communication with the central lumen, housing at least one imagingdevice configured for distal imaging; said proximal end comprising ahandle with a means for connecting the imaging device(s) to an imagingdisplay(s), and a means for accessing bodily tissue in the vicinity ofthe objective lens, a CMOS imaging sensor, and at least one lightemitting diode configured for tissue illumination.

In accordance with another aspect of this invention is a surgical devicecomprising an elongated rigid structure with a distal end, a proximalend, and a central lumen; with said distal end comprising a non-coringoptically transparent needle tip with at least one lateral fenestrationin communication with the central lumen, housing at least one imagingdevice configured for distal imaging; said proximal end comprising ahandle with a means for connecting the imaging device(s) to an imagingdisplay(s), and a means for accessing bodily tissue in the vicinity ofthe distal end with a cryo-surgical probe through the central lumen andthe lateral fenestration(s) for diagnostic or therapeutic purposes,whereby the imaging device is an endoscope comprising an objective lens,a coherent fiber optic bundle configured for imaging, and a secondoptical bundle configured for illumination.

In accordance with another aspect of this invention is a surgical devicecomprising an elongated rigid structure with a distal end, a proximalend, and a central lumen; with said distal end comprising a non-coringoptically transparent needle tip with at least one lateral fenestrationin communication with the central lumen, housing at least one imagingdevice configured for distal imaging; said proximal end comprising ahandle with a means for connecting the imaging device(s) to an imagingdisplay(s), and a means for accessing bodily tissue in the vicinity ofthe distal end with a cryo-surgical probe through the central lumen andthe lateral fenestration(s) for diagnostic or therapeutic purposes,whereby the imaging device is an endoscope comprising an objective lens,and at least one relay lens configured for tissue imaging, and a fiberoptic bundle configured for tissue illumination.

In accordance with another aspect of this invention is a surgical devicecomprising an elongated rigid structure with a distal end, a proximalend, and a central lumen; with said distal end comprising a non-coringoptically transparent needle tip with at least one lateral fenestrationin communication with the central lumen, housing at least one imagingdevice configured for distal imaging; said proximal end comprising ahandle with a means for connecting the imaging device(s) to an imagingdisplay(s), and a means for accessing bodily tissue in the vicinity ofthe distal end with a cryo-surgical probe through the central lumen andthe lateral fenestration(s) for diagnostic or therapeutic purposes,whereby the minor dimension of the lateral fenestration approximates theworking diameter of the central lumen.

In accordance with another aspect of this invention is a surgical devicecomprising an elongated rigid structure with a distal end, a proximalend, and a central lumen; with said distal end comprising a non-coringoptically transparent needle tip with at least one lateral fenestrationin communication with the central lumen, housing at least one imagingdevice configured for distal imaging; said proximal end comprising ahandle with a means for connecting the imaging device(s) to an imagingdisplay(s), and a means for accessing bodily tissue in the vicinity ofthe distal end with a cryo-surgical probe through the central lumen andthe lateral fenestration(s) for diagnostic or therapeutic purposes,whereby the lateral fenestration is substantially perpendicular to theaxis of the central lumen.

In accordance with another aspect of this invention is a surgical devicecomprising an elongated rigid structure with a distal end, a proximalend, and a central lumen; with said distal end comprising a non-coringoptically transparent needle tip with at least one lateral fenestrationin communication with the central lumen, housing at least one imagingdevice configured for distal imaging, and at least one cryosurgicalprobe configured for distal tissue freezing; said proximal endcomprising a handle with a means for connecting the imaging device(s) toan imaging through the central lumen and the lateral fenestration(s) fordiagnostic or therapeutic purposes, whereby the fluid is a clear ionicliquid.

In accordance with another aspect of this invention is a surgical devicecomprising an elongated rigid structure with a distal end, a proximalend, and a central lumen; with said distal end comprising a non-coringoptically transparent needle tip with at least one lateral fenestrationin communication with the central lumen, housing at least one imagingdevice configured for distal imaging, and at least one cryosurgicalprobe configured for distal tissue freezing; said proximal endcomprising a handle with a means for connecting the imaging device(s) toan imaging display(s), and a means for delivering or removing fluidto/from the vicinity of the distal end through the central lumen and thelateral fenestration(s) for diagnostic or therapeutic purposes, wherebythe fluid is pressurized to facilitated dissection and distaladvancement.

In accordance with another aspect of this invention is a surgical devicecomprising an elongated rigid structure with a distal end, a proximalend, and a central lumen; with said distal end comprising a non-coringoptically transparent needle tip with at least one lateral fenestrationin communication with the central lumen, housing at least one imagingdevice configured for distal imaging, and at least one cryosurgicalprobe configured for distal tissue freezing; said proximal endcomprising a handle with a means for connecting the imaging device(s) toan imaging display(s), and a means for delivering or removing fluid fromthe vicinity of the distal end through the central lumen and the lateralfenestration(s) for diagnostic or therapeutic purposes, whereby thefluid is an evaporated liquid refrigerant that is introduced to thedistal region by the cryosurgical probe during distal tissue freezing.

In accordance with another aspect of this invention is a surgical devicecomprising an elongated rigid structure with a distal end, a proximalend, and a central lumen; with said distal end comprising a non-coringoptically transparent needle tip with at least one lateral fenestrationin communication with the central lumen, housing at least one imagingdevice configured for distal imaging, and at least one cryosurgicalprobe configured for distal tissue freezing; said proximal endcomprising a handle with a means for connecting the imaging device(s) toan imaging display(s), and a means for delivering or removing fluidto/from the vicinity of the distal end through the central lumen and thelateral fenestration(s) for diagnostic or therapeutic purposes, wherebythe fluid is comprises an anesthetic.

In accordance with another aspect of this invention is a surgical devicecomprising an elongated rigid structure with a distal end, a proximalend, and a central lumen; with said distal end comprising a non-coringoptically transparent needle tip with at least one lateral fenestrationin communication with the central lumen, housing at least one imagingdevice configured for distal imaging; said proximal end comprising ahandle with a means for connecting the imaging device(s) to an imagingdisplay(s), and a means for accessing bodily tissue in the vicinity ofthe distal end through the central lumen and the lateral fenestration(s)for diagnostic or therapeutic purposes, whereby the handle, centrallumen, and lateral fenestration are configured to receive a surgicalprobe for surgical access to distal tissue, wherein the surgical probemay be a cryosurgical probe configured for distal tissue freezing.

In accordance with another aspect of this invention is a surgical devicecomprising an elongated rigid structure with a distal end, a proximalend, and a central lumen; with said distal end comprising a non-coringoptically transparent needle tip with at least one lateral fenestrationin device(s) to an imaging display(s), and a means for accessing bodilytissue in the vicinity of the distal end through the central lumen andthe lateral fenestration(s) for diagnostic or therapeutic purposes,whereby the handle, central lumen, and lateral fenestration areconfigured to receive a surgical probe for surgical access to distaltissue, wherein the surgical probe may be a cryosurgical probeconfigured for distal tissue freezing by means of direct application ofliquid refrigerant to the target distal tissue.

In accordance with another aspect of this invention is a surgical devicecomprising an elongated rigid structure with a distal end, a proximalend, and a central lumen; with said distal end comprising a non-coringoptically transparent needle tip with at least one lateral fenestrationin communication with the central lumen, housing at least one imagingdevice configured for distal imaging; said proximal end comprising ahandle with a means for connecting the imaging device(s) to an imagingdisplay(s), and a means for accessing bodily tissue in the vicinity ofthe distal end through the central lumen and the lateral fenestration(s)for diagnostic or therapeutic purposes, whereby the handle, centrallumen, and lateral fenestration are configured to receive a surgicalprobe for surgical access to distal tissue, wherein the surgical probemay be a cryosurgical probe configured for distal tissue freezingcomprising a distal refrigerant evaporation chamber in direct contactwith the target distal tissue, with the evaporation chamber comprising ahollow metallic structure.

In accordance with another aspect of this invention is a surgical devicecomprising an elongated rigid structure with a distal end, a proximalend, and a central lumen; with said distal end comprising a non-coringoptically transparent needle tip with at least one lateral fenestrationin communication with the central lumen, housing at least one imagingdevice configured for distal imaging; said proximal end comprising ahandle with a means for connecting the imaging device(s) to an imagingdisplay(s), and a means for accessing bodily tissue in the vicinity ofthe distal end through the central lumen and the lateral fenestration(s)for diagnostic or therapeutic purposes, whereby the handle, centrallumen, and lateral fenestration are configured to receive a surgicalprobe for surgical access to distal tissue, wherein the surgical probemay be a cryosurgical probe configured for distal tissue freezingcomprising a distal refrigerant evaporation chamber in direct contactwith the target distal tissue, with the evaporation chamber comprisingan inflatable balloon.

In accordance with another aspect of this invention is a method foraccessing a distal region in a mammalian body through a naturaldissection plane in order to perform at least one diagnostic ortherapeutic cryosurgical step comprising inserting into the body asurgical device comprising an elongated rigid structure with a distalend, a proximal end, and a central lumen; with said distal endcomprising a non-coring optically transparent needle tip with at leastone lateral fenestration in communication with the central lumen, andhousing at least one imaging device configured for distal imaging, andhousing at least one removable cryosurgical probe configured for distaltissue freezing; said proximal end comprising a handle with a means forconnecting the imaging device(s) to an imaging display(s), and a meansfor accessing bodily tissue in the vicinity of the distal end throughthe central lumen and the lateral fenestration(s); then advancing thesurgical device in the direction of the distal region while maneuveringthe distal tip between the facial boundaries of intervening anatomicalstructures using images from the imaging device(s) and imagingdisplay(s) to guide the maneuvering.

In accordance with another aspect of this invention is a method foraccessing a distal region in a mammalian body through a naturaldissection plane in order to perform at least one diagnosticfenestration in communication with the central lumen, and housing atleast one imaging device configured for distal imaging, and furthercomprising an inflatable structure proximal to the needle tip; saidproximal end comprising a handle with a means for connecting the imagingdevice(s) to an imaging display(s), and a means for accessing bodilytissue in the vicinity of the distal end through the central lumen andthe lateral fenestration(s) for diagnostic or therapeutic purposes, anda means for inflating the inflatable structure; then advancing thesurgical device in the direction of the distal region while maneuveringthe distal tip between the facial boundaries of intervening anatomicalstructures using images from the imaging device(s) and imagingdisplay(s) to guide the maneuvering, and inflating the inflatablestructure as needed to facilitate distal advancement.

In accordance with an alternative embodiment of this invention is acryosurgical probe comprising an elongated structure with a distal end,a proximal end, and at least one central lumen; with said distal endcomprising an inflatable balloon structure configured as a refrigerantevaporation chamber, and as an optical imaging window, enclosing atleast one optical imaging device; with said proximal end comprising ameans for introducing a liquid refrigerant into the distal balloonthrough a central lumen, a means of removing evaporated refrigerant fromthe cryosurgical probe at a predetermined pressure, a means forconnecting the optical imaging device(s) to an imaging display, and ameans for inflating the balloon with a liquid or a gas.

An alternative embodiment of this invention is a cryosurgical probecomprising an elongated structure with a distal end, a proximal end, andat least one central lumen; with said distal end comprising aninflatable balloon structure configured as a refrigerant evaporationchamber, and as an optical imaging window, enclosing at least oneoptical imaging device; with said proximal end comprising a means forintroducing a liquid refrigerant into the distal balloon through acentral lumen, a means of removing evaporated refrigerant from thecryosurgical probe at a predetermined pressure, a means for connectingthe optical imaging device(s) to an imaging display, and a means forinflating the balloon with a liquid or a gas.

In accordance with one aspect of the alternative embodiment of thisinvention is a cryosurgical probe comprising an elongated structure witha distal end, a proximal end, and at least one central lumen; with saiddistal end comprising an inflatable balloon structure configured as arefrigerant evaporation chamber, and as an optical imaging window,enclosing at least one optical imaging device; with said proximal endcomprising a means for introducing a liquid refrigerant into the distalballoon through a central lumen, a means of removing evaporatedrefrigerant from the cryosurgical probe at a predetermined pressure, ameans for connecting the optical imaging device(s) to an imagingdisplay, and a means for inflating the balloon with a liquid or a gas,whereby, the imaging device is configured for lateral imaging.

In accordance with another aspect of the alternative embodiment of thisinvention is a cryosurgical probe comprising an elongated structure witha distal end, a proximal end, and at least one central lumen; with saiddistal end comprising an inflatable balloon structure configured as arefrigerant evaporation chamber, and as an optical imaging window,enclosing at least one optical imaging device; with said proximal endcomprising a means for introducing a liquid refrigerant into the distalballoon through a central lumen, a means of removing evaporatedrefrigerant from the cryosurgical probe at a predetermined pressure, ameans for connecting the optical imaging device(s) to an imagingdisplay, and a means for inflating the balloon with a liquid or a gas,whereby, the imaging device comprises at least one coherent opticalfiber bundle, configured for transmitting an image from within theinflatable balloon to a camera in the vicinity of the proximal end.

In accordance with another aspect of the alternative embodiment of thisinvention is a cryosurgical probe comprising an elongated structure witha distal end, a proximal end, and at least one central lumen; with saiddistal end comprising an inflatable balloon structure configured as arefrigerant evaporation chamber, an optical imaging window, and as atissue dilator enclosing at least one optical imaging device; with saidproximal end comprising a means for introducing a liquid refrigerantinto the distal balloon through a central lumen, a means of removingevaporated refrigerant from the cryosurgical probe at a predeterminedpressure, a means for connecting the optical imaging device(s) to animaging display, and a means for inflating the balloon with a liquid ora gas, whereby, the imaging device comprises a probe with a distal endand a proximal end configured for removable insertion into theinflatable balloon through a central lumen, with the distal endcomprising an imaging means, and the proximal end comprising a means forconnecting the probe to an image display.

In accordance with another aspect of the alternative embodiment of thisinvention is a cryosurgical probe comprising a substantially rigidelongated structure with a distal end, a proximal end, and at least onecentral lumen; with said distal end comprising an inflatable balloonstructure configured as a refrigerant evaporation chamber, an opticalimaging window, and as a tissue dilator enclosing at least one opticalimaging device; with said proximal end comprising a means forintroducing a liquid refrigerant into the distal balloon through acentral lumen, a means of removing evaporated refrigerant from thecryosurgical probe at a predetermined pressure, a means for connectingthe optical imaging device(s) to an imaging display, and a means forinflating the balloon with a liquid or a gas, whereby the cryosurgicalprobe is configured for insertion into the targeted surgical site.

In accordance with another aspect of the alternative embodiment of thisinvention is a cryosurgical probe comprising a substantially flexibleelongated structure with a distal end, a proximal end, and at least onecentral lumen; with said distal end comprising an inflatable balloonstructure configured as a refrigerant evaporation chamber, an opticalimaging window, and as a tissue dilator enclosing at least one opticalimaging device; with said proximal end comprising a means forintroducing a liquid refrigerant into the distal balloon through acentral lumen, a means of removing evaporated refrigerant from thecryosurgical probe at a predetermined pressure, a means for connectingthe optical imaging device(s) to an imaging display, and a means forinflating the balloon with a liquid or a gas, whereby the cryosurgicalprobe is configured for insertion into the targeted surgical site bymeans of a tortuous insertion pathway.

In accordance with another aspect of the alternative embodiment of thisinvention is a cryosurgical probe comprising an elongated structure witha distal end, a proximal end, and at least one central lumen; with saiddistal end comprising an inflatable balloon structure configured as arefrigerant evaporation chamber, an optical imaging window, and as atissue dilator enclosing at least one optical imaging device; with saidproximal end comprising a means for introducing a liquid refrigerantinto the distal balloon through a central lumen, a means of removingevaporated refrigerant from the cryosurgical probe at a predeterminedpressure, a means for connecting the optical imaging device(s) to animaging display, and a means for inflating the balloon with a liquid ora gas, whereby the predetermined pressure is maintained by a pressurerelief valve in line between the interior of the balloon and the ambientatmosphere, wherein the cryosurgical probe is configured for lateraltissue freezing by means of spraying a liquid refrigerant at an interiorradial segment of the balloon from a central lumen. cryosurgical probecomprising an elongated structure with a distal end, a proximal end, andat least one central lumen; with said distal end comprising an outerinflatable balloon structure configured as an optical imaging window,and as a tissue dilator enclosing at least one optical imaging device,at least one inner cryogenic evaporator balloon, and at least one innerthermal insulation balloon; with said proximal end comprising a meansfor introducing a liquid refrigerant into the cryogenic evaporatorballoon through a central lumen, a means of removing evaporatedrefrigerant from the cryogenic evaporator balloon through a centrallumen at a predetermined pressure, a means for inflating the thermalinsulation balloon with the pressurized evaporated refrigerant gas, ameans for connecting the optical imaging device(s) to an imagingdisplay, and a means for inflating the outer balloon with a liquid or agas.

In accordance with another aspect of the alternative embodiment of thisinvention is a cryosurgical probe comprising an elongated structure witha distal end, a proximal end, and at least one central lumen; with saiddistal end comprising an outer inflatable balloon structure configuredas an optical imaging window, and as a tissue dilator enclosing at leastone optical imaging device, at least one inner cryogenic evaporatorballoon, and at least one inner thermal insulation balloon; with saidproximal end comprising a means for introducing a liquid refrigerantinto the cryogenic evaporator balloon through a central lumen, a meansof removing evaporated refrigerant from the cryogenic evaporator balloonthrough a central lumen at a predetermined pressure, a means forinflating the thermal insulation balloon with the pressurized evaporatedrefrigerant gas, a means for connecting the optical imaging device(s) toan imaging display, and a means for inflating the outer balloon with aliquid or a gas, whereby the outer balloon is fabricated from asubstantially non-elastic material, and the inner balloons arefabricated from a substantially elastic material.

In accordance with another aspect of the alternative embodiment of thisinvention is a cryosurgical probe comprising an elongated structure witha distal end, a proximal end, and at least one central lumen; with saiddistal end comprising an outer inflatable balloon structure configuredas an optical imaging window, and as a tissue dilator enclosing at leastone removably insertable optical imaging device, at least one innercryogenic evaporator balloon, and at least one inner thermal insulationballoon; with said proximal end comprising a means for introducing aliquid refrigerant into the cryogenic evaporator balloon through acentral lumen, a means of removing evaporated refrigerant from thecryogenic evaporator balloon through a central lumen at a predeterminedpressure, a means for inflating the thermal insulation balloon with thepressurized evaporated refrigerant gas, a means for connecting theoptical imaging device(s) to an imaging display, and a means forinflating the outer balloon with a liquid or a gas, whereby the innerballoons are configured to conform to the inner surface of the outerballoon when pressurized with refrigerant.

It is further an object of this invention to provide a method forperforming a cryosurgical procedure comprising inserting a cryosurgicalprobe into the body of a patient, and then advancing the distal end ofthe probe into the vicinity of the surgical target, with thecryosurgical probe comprising: an elongated structure with a distal end,a proximal end, and at least one central lumen; with said distal endcomprising an inflatable balloon structure configured as a refrigerantevaporation chamber, and as an optical imaging window enclosing at leastone optical imaging device; with said proximal end comprising a meansfor introducing a liquid refrigerant into the distal balloon through acentral lumen, a means of removing evaporated refrigerant from thecryosurgical probe at a predetermined pressure, a means for connectingthe optical imaging device(s) to an imaging display, and a means forinflating the balloon with a liquid or a gas; then inflating the balloonand imaging the anatomy surrounding the balloon, then determiningwhether the cryosurgical probe is in a correct position for cryosurgicalablation based at least in part on the imaging, then, if thedetermination is that the cryosurgical probe is in a correct positionthen proceeding with the cryosurgical ablation, and alternatively, ifthe determination is that the cryosurgical probe is not in the correctposition, then repositioning the cryosurgical probe until thecryosurgical probe is in a correct position, as determined at least inpart by the imaging, whereby determining correct position may comprisedetermining the position of a lateral tissue freezing zone of thecryosurgical probe in relation to the adjacent anatomy.

An additional object of this invention is a method for cryosurgicalablation of the function of a nerve comprising inserting a cryosurgicalprobe between the target nerve and the artery and vein associated withthe nerve; with the cryosurgical probe having an elongated structurewith a distal end, a proximal end, and at least one central lumen; withsaid distal end comprising an outer inflatable balloon structureconfigured as an optical imaging window, and as a tissue dilatorenclosing at least one optical imaging device, at least one innercryogenic evaporator balloon, and at least one inner thermal insulationballoon; with said proximal end comprising a means for introducing aliquid refrigerant into the cryogenic evaporator balloon through acentral lumen, a means of removing evaporated refrigerant from thecryogenic evaporator balloon through a central lumen at a predeterminedpressure, a means for inflating the thermal insulation balloon with thepressurized evaporated refrigerant gas, a means for connecting theoptical imaging device(s) to an imaging display, and a means forinflating the outer balloon with a liquid or a gas; then inflating theouter balloon to create distance between the nerve and the vein andartery; then using the imaging device, position the inner cryo balloonproximate to the nerve, and the inner insulation balloon proximate tothe vein and artery; then introducing liquid refrigerant into the cryoballoon causing inflation of the inner cryo balloon and the innerinsulation balloon; then maintaining the flow of refrigerant for aperiod of time sufficient for affecting the nerve function in thedesired manner, whereby, the vein and artery remain unaffected by colddue to the separation between the target nerve end the vein and artery,and the thermal insulating effect of the inner thermal insulationballoon.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of a surgical imaging probe configuredfor accessing a distal surgical site within a patient using imageguidance.

FIG. 2 shows a perspective view of the distal end of the surgical probehaving an optically transparent needle tip mounted on the probe shaft.

FIG. 3 shows a cross sectional illustration of the distal end of thesurgical probe depicting the probe shaft, optically transparent needletip, and imaging element.

FIG. 4 shows a cross sectional illustration of the distal end of thesurgical probe which is configured for direct application of a liquidrefrigerant on target tissue within the field of view of the imagingelement.

FIGS. 5A and 5B show cross sectional side views of the distal end of thesurgical probe illustrating a cryosurgical balloon probe having aballoon member which is inflatable upon introduction of a liquidrefrigerant.

FIG. 6A shows a schematic illustration of a surgical probe inserted intothe body of a patient and advanced through tissue towards the targetdistal region while under visual guidance.

FIG. 6B shows an illustration of an image received from the imagingelement positioned within the probe.

FIG. 6C shows an illustration of an image from imaging element showingthe target distal region residing between facial surfaces which havebeen separated by the manipulation of the surgical probe.

FIG. 7A shows a side view of a variation of the distal end of an ImageGuided Directed Cryosurgical Balloon (IGCB) probe.

FIG. 7B shows a cross sectional end view of the IGCB probe.

FIG. 7C shows a schematic illustration of a variation of the proximalterminal of the IGCB probe.

FIG. 8 shows a cross sectional schematic side view of a variation of thedistal end of a lateral optical imaging probe.

FIG. 9A shows the distal end of the IGCB probe with an inflated outerballoon and a lateral optical imaging probe imaging the surroundinganatomy from within the outer balloon as represented by field of view.

FIG. 9B shows the distal end of IGCB probe 101 with the outer balloonremoved for clarity to reveal an inner cryo balloon in a deflatedconfiguration and an inner thermal insulation balloon in a deflatedconfiguration.

FIG. 9C shows a cross sectional side view of the distal end of the IGCBprobe.

FIG. 10 shows a cross sectional end view of the IGCB probe takenproximal to the inflatable outer balloon.

FIG. 11 shows a cross section side view of the distal end of the IGCBprobe during a cryosurgical procedure.

FIG. 12 shows a transverse cross sectional end view of the IGCB probeillustrating cryogenic fluid being sprayed at an inner wall of the innerballoon.

FIG. 13 shows a schematic illustration of the proximal terminal of theIGCB probe.

FIG. 14 shows a cross sectional end view of a nerve undergoingcryo-ablation using the IGCB probe.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is an illustration of the central embodiment of surgical imagingprobe 1 configured for accessing a distal surgical site within a patientby advancement between anatomical structures by atraumatic bluntdissection using image guidance for the purpose of performing acryosurgical step. Surgical imaging probe 1 comprises probe shaft 2,non-coring optically transparent needle tip 3, probe handle 8,electrical lead 4, electrical connector 5 fluid tube 6 and fluidconnector 7. Probe shaft 2 is between approximately 5 and 20 centimeterslong, and between approximately 2.5 and 3.5 millimeters in diameter.Probe shaft 2 has a central lumen between approximately 2.3 and 3.3millimeters in diameter. Probe shaft 2 may be fabricated from astainless steel hypodermic tube, or may be fabricated from another metalused in surgical instruments such as titanium. Probe shaft 2 issubstantially rigid and is capable of transmitting lateral,longitudinal, and torsional forces along its length. Distal needle tip 3is configured for blunt atraumatic dissection between the fascias ofdiscrete anatomical structures. Distal needle tip 3 is opticallytransparent and houses an optical imaging device that is connectable toan imaging display. The optical images are used by the surgeon identifya facial plane through which the surgical probe may safely be advancedtowards a target distal region within the body. Distal needle tip 3 alsocomprises a lateral fenestration which communicates with the interior ofdistal needle tip 3, and the central lumen of probe shaft 2. Distalneedle tip 3, probe shaft 2 are described in greater detail below.Surgical probe handle 8 is configured in an ergonomic manner to providethe surgeon with a comfortable grip of surgical probe 1, and goodtactile feedback of the forces resulting from manipulation of surgicalprobe 1 during the surgery. Surgical probe handle 8 also comprises ameans for fluid communication between fluid tube 6 and the central lumenin probe shaft 2. Fluid connector 7 is a female luer fitting as depictedand is configured for connection to a syringe or another fluid source.Additionally, a cryosurgical surgical probe may be inserted throughsurgical probe 1 for distal use using fluid connector 7, fluid tube 6,the central lumen of probe shaft 5 and exiting through the lateralfenestration of needle tip 3. Electrical lead 4, and electricalconnector 5 are configured to connect the optical imaging device mountedwithin needle tip 3 to an optical imaging display. Electrical lead 4,and electrical connector 5 may provide a means for connecting additionalsensors mounted within surgical probe 1 that may include sensorsconfigured to detect temperature, cardiac signals, bodily fluidchemistry, dissecting force, fluid pressure, ionizing radiation,non-visible light, or a magnetic field. Electrical lead 4 and electricalconnector may be configured for connecting a therapeutic energy emittingdevice mounted within surgical probe 1 to a source of therapeuticenergy.

FIG. 2 is an illustration of the distal end of surgical probe 1 showingthe distal end of probe shaft 2, with optically transparent needle tip 3mounted on probe shaft 2. Needle tip 3 comprises a non-coring needle tipdesign where the distal face of the needle tip is smooth with a largeradius 10 as shown, and comprises a lateral fenestration 9 thatcommunicates between the distal exterior of surgical probe 1 and theinterior of needle tip 3 and the central lumen of probe shaft 2.Radiused edge 11 is configured to smooth the edge formed between largeradiused surface 10 and fenestration 9 to prevent puncture or incisionof tissue as surgical 1 is advanced in the distal direction betweenanatomical structures.

FIG. 3 is a cross sectional illustration of the distal end of surgicalprobe 1 depicting probe shaft 2, optically transparent needle tip 3,CMOS camera with integral illumination 12, camera mount 13, centrallumen 16, electrical cable 14, and camera field of view 15. Probe shaft2 comprises central lumen 16, and a stepped segment 17 configured formounting needle tip 3. Needle tip 3 is fabricated from an opticallytransparent, mechanically rigid material, which may a glass material, ormay be a plastic material such as polycarbonate. Those skilled in theart of glass forming, or plastic molding of optical components arefamiliar the fabrication techniques that may be used for fabricatingneedle tip 3 as disclosed here within, therefore no further descriptionis warranted. Needle tip 3 is a hollow tubular structure with a centralaxis substantially aligned with the central axis of probe shaft 2 at itsproximal end, and with the central axis substantially perpendicular tothe central axis of probe shaft 2 as shown. The distal face is blunt asdefined by large radius 10. Fenestration 9 communicates between theinterior of needle tip 3 and central lumen 16, and the exterior ofsurgical probe 1. Fenestration 9 may be configured as shown, or mayalternatively be more than one single fenestration. Fenestration 9 mayhave a diameter that is similar to the diameter of central lumen 16 andsuitable for passing a surgical instrument through, or may besubstantially smaller than central lumen 16. Camera 12 may be aminiature CMOS camera with integral illumination and similar to camerasoffered by Awaiba Corp. which are described in detail at www.awaiba.com,and therefore no further description is warranted here. Camera 12 ismounted to the inner surface of needle tip 3 by camera mount 13, whichis configured to point camera 12 so field of view 15 is in the distaldirection, and substantially encompasses fenestration 9 as shown. Analternate optical imaging device, not show may be employed for distalimaging, which may be a fiberscope, of a rigid endoscope mounted withincentral lumen 16. Camera mount 13 may be integrally molded into needletip 3 as shown, or may be separate component that is bonded to theinterior of needle tip 3. Electrical cable 14 connects camera 12 toelectrical connector 5 at the proximal end of surgical probe 1, andresides within central lumen 16 as shown.

FIG. 4 is a cross sectional illustration of the distal end of surgicalprobe 1 depicting cryosurgical probe 18, which is configured for directapplication of liquid refrigerant on target tissue to effect tissuefreezing. As shown cryosurgical probe 18 is extending from central lumen16 and needle tip 3 in position for spraying liquid refrigerant 50through distal cryo-nozzle 49 on target distal tissue within the fieldof view 15 of camera 12. Also as depicted, evaporated refrigerant 51 isvented back to ambient atmosphere through central lumen 16. Camera 12may be used to monitor and guide tissue freezing. Cryosurgical probe 18may comprise a steerable distal segment that may be utilized to directthe spray of liquid refrigerant. Those skilled in the art of steerablecatheters are familiar with designs and manufacturing process forincorporating steerable function into cryosurgical probe 18, thereforeno further description is warranted.

FIG. 5A is a cross sectional illustration of the distal end of surgicalprobe 1 configured for distal tissue ablation utilizing cryosurgicalprobe 52 comprising a closed distal evaporator chamber 53, which freezestarget tissue by contact with the surface of evaporator 53, and bythermal conduction of heat from the target tissue into evaporatorchamber 53. Cryosurgical probes with closed distal evaporation chambersare thoroughly and widely described in the prior art, therefore nofurther description of cryosurgical probe 52 is warranted. FIG. 5B is across sectional illustration of the distal end of surgical probe 1configured for distal tissue ablation utilizing cryosurgical balloonprobe 54 comprising a closed distal evaporator balloon chamber 55, whichinflates upon introduction of liquid refrigerant into the interior ofballoon 55 and freezes target tissue by contact with the surface ofballoon 55, and by thermal conduction of heat from the target tissueinto evaporator balloon chamber 55. Cryosurgical probes with closeddistal evaporation balloon chambers are thoroughly and widely describedin the prior art, therefore no further description of cryosurgical probe54 is warranted.

FIG. 6A is a schematic illustration of surgical probe 1 being insertedinto the body of a patient 30 and being advanced in a distal directionthrough tissue 31 towards target distal region 32 under visual guidance.Surgical probe 1 may be manipulated in torsional and lateral directionsas represented by the crossed arrows in order to find a facial boundarybetween two or more discrete anatomical structures through whichsurgical probe 1 may be safely advanced in the distal direction towardsthe target distal region 32. FIG. 6B is an illustration showing an imagefrom camera 12. Visible in the image is distal tissue comprisingdiscrete anatomical structures 36, and 35, which is separated by facialboundary 34. Fenestration 9 is shown in full view. FIG. 6C is anillustration showing an image from camera 12 showing the target distalregion 32 residing between facial surfaces 37 and 38, which have beenseparated by the manipulation of surgical probe 1 facilitating one ormore surgical therapeutic or diagnostic step(s), including a possiblecryosurgical step, as depicted by frozen tissue 56.

FIGS. 7A, 7B and 7C are schematic illustrations of Image Guided DirectedCryosurgical Balloon (IGCB) probe 60. IGCB Probe 60 comprises probeshaft 61, balloon 62, distal tip 63, optical imaging probe 64, cryogentube 65, and proximal terminal 66.

FIG. 7A depicts the distal end of IGCB probe 60 showing balloon 62bonded to probe shaft 61 at its proximal end, and bonded to distal tip63 at its distal end. Also shown is cryogen tube 65 mounted betweenprobe shaft 61 and distal tip 63. Cryogen tube 63 comprises a lineararray of lateral cryogen nozzles 67. Lateral cryogen nozzle array 67 aresmall fenestrations through on wall of cryogen tube 65, and are betweenapproximately 50 and 150 microns in diameter, and number between one andapproximately 20 or more. Lateral cryogen nozzles 67 may formed by alaser machining operation. Cryogen tube 65 is connectable to a source ofcryogenic liquid at proximal terminal 66, and is configured to spray alateral region of balloon 62 with liquid cryogen to form lateral tissuefreezing zone 68. Cryo tube 65 and balloon 62 are configured so thatsubstantially all of the liquid cryogen sprayed at the inner wall ofballoon 62 is evaporated on contact, and balloon 62 is substantiallyfilled with cryogen in a gaseous state, which is thermally insulative,thereby limiting tissue freezing to tissue adjacent to tissue freezingzone 68. Cryo tube 65 is also configured to mechanically link probeshaft 61 to distal tip 63 and to translate axial and lateral forcesbetween probe shaft 61 and distal tip 63 to a degree sufficient tomaneuver IGCB probe 60 into position within a mammalian body for thepurpose of performing at least one cryosurgical step. The inner lumen ofcryogen tube 65 is terminated and sealed at distal tip 63, thereby, allcryogen leaves cryogen tube 65 through lateral cryogen nozzle array 67.Cryogen tube 65 may be fabricated from stainless steel or Nitinol®hypodermic tube. Optical imaging probe 64 may be removably inserted intothe interior of balloon 62 though central lumen 69, and imaging port 70of proximal terminal 66 (See FIG. 7C). Optical imaging probe 64 isconfigured for lateral imaging as depicted by imaging field of view 71.Optical imaging probe 64 and IGCB probe 60 are configured with animaging range of motion that is substantially 360 degrees of lateralimaging, and with an axial range that approximates the length of theballoon 62. Imaging probe 64 is described in greater detail below.Balloon 62 is configured for tissue dilation, and as an optical windowfor optical imaging probe 64. Balloon 62 may be fabricated from asubstantially in-elastic material with good optical clarity such PET.Balloon 62 is configured to have a burst strength of betweenapproximately 4 and 12 atmospheres of pressure, at a cryogenictemperature between zero, and minus 100 degrees centigrade. Balloon 62is bonded using an adhesive to the distal end of probe shaft 61, and theproximal end of distal tip 63 as shown. Balloon 62 may be inflated (asshown) with a liquid or a gas though at least one central lumen in probeshaft 61, and a fluid port on proximal terminal 66, which is describedin detail below. Balloon 62 may also be inflated during cryogen sprayingusing the expansion of the evaporating cryogen and a pressure regulatingvalve mounted within distal terminal 66 disposed between the interior ofballoon 62 and the ambient atmosphere, which is described in more detailbelow. Those skilled in the art of surgical balloon probe design andmanufacture are familiar with means for designing and manufacturing IGCBprobe as disclosed here within, therefore, no further explanation iswarranted. Probe shaft 61 may be substantially rigid, and fabricated asa metal extrusion, or may be substantially flexible and fabricated froma plastic material such as urethane, PeBax®, nylon, or polyethylene.Distal tip 63 may be bullet shaped as shown, and may have a guidewirechannel 77 as shown for assisting in positioning IGCB probe 60 intoposition for performing a cryosurgical step. Distal tip 63 may be amolded or extruded plastic material, or may be machined from metal.

FIG. 7B is a sectional illustration taken at section A-A in FIG. 7A.Depicted in FIG. 7B is cryogen 75 being sprayed against a lateralsection of balloon 62 (lateral tissue freezing zone 68) through lateralcryogen nozzle array 67 in cryogen tube 65. Also shown is ice ball 72formed in tissue adjacent to lateral tissue freezing zone 68. Opticalimaging probe 64 is shown imaging tissue diametrically opposed tolateral tissue freezing zone 68. Also depicted are balloon lumens 73 and74 which are in fluidic communication with proximal terminal 66. Balloonlumens 73 and 74 may be used to together or separately for inflating theballoon with a liquid or gas prior to or after tissue freezing, and areused to vent evaporated cryogen from balloon 62.

FIG. 7C is a schematic illustration of proximal terminal 66 of IGCBprobe 60. Hub 78 fluidically connects balloon lumens 73 and 74 toballoon lumen hub tube 79, cryogen tube 65 to cryogen hub tube 85, andprovides an insertion path for optical probe 64 into optical probe lumen69 though optical probe port 86 and optical probe hub tube 87. Hub 78 ininsert molded using mandrels to create discrete channels between the hubtubes and lumens described above. Those skilled in the art of surgicalprobe hub design and manufacture are familiar methods for designing andmanufacturing the an IGCB probe hub as disclosed here within, thereforeno further description is warranted. Imaging probe 64 is inserted intoimaging probe lumen 69 through imaging probe port 86 and imaging probehub tube 87. Imaging probe port 86 may comprise a Toughy Borstconnector, or another type of surgical pressure port. Imaging module 88comprises a camera and a light source. The camera images the proximalend of the coherent optical fiber bundle of imaging probe 64, and thelight source provides illumination to the distal surgical field, withthe light being transmitted distally by a second optical fiber or fiberbundle. Optical imaging probe 64 will be described in further detailbelow. Imaging module 88 is connected to an imaging display, not shown.Cryogen tube 65 is connected to a source of liquid cryogen 90 by meansof cryogen port 84, cryogen source hose 91, and cryogen connector 92.Liquid cryogen source 90 is depicted schematically as a cryogen tank.The liquid cryogen source may comprise a control console that controlsthe flow of cryogen based on user settings, and feedback from sensors,not shown. The liquid cryogen may be liquid carbon dioxide or liquidnitrogen, or a liquid chlorofluorocarbon compound. Alternatively,instead of using evaporative cooling, a Joules-Thompson effect(adiabatic gas expansion) cooling architecture could employed and stillbe within the scope of this invention. Nitrous oxide or argon gas wouldbe the preferred cryogenic gasses for use if a Joule-Thompson coolingarchitecture is employed. Those skilled in the art cryosurgical probedesign and manufacture are familiar the design attributes and trade-offsbetween liquid cryogen evaporative cooling and Joule-Thompson effectcooling architectures, and are familiar with the means for employingeither cooling architecture within the scope of this invention,therefore no further discussion is warranted. Balloon lumens 73 and 74are in fluidic communication with balloon lumen hub tube 79. Stop cock80 provides the user a means to either inflate balloon 62 prior to orafter a cryosurgical step using syringe 81. Syringe 81 may also be usedto deflate balloon 62. During a cryosurgical step, the stop cock isconfigured to fluidically connect pressure relief valve 82 to balloonlumen hub tube 79, and fluidically disconnect syringe 81 from balloonlumen hub tube 79. Pressure relief valve 82 vents evaporated cryogen 83to the ambient atmosphere while maintaining a set pressure with balloon62 during liquid cryogen delivery. The pressure created by pressurerelief valve 82 is used to maintain inflation and tissue dilation forcefor balloon 62 in order to maintain a spatial separation between tissuetargeted for freezing, and tissue intended to be protected fromfreezing. Pressure relief valve 82 may have a fixed preset pressurerelief setting, or pressure relief valve 82 may have a user adjustablepressure setting within a range of pressures that are lower than theburst strength of balloon 62. Pressure relief valve 82 may also comprisean audible indication of the volumetric flow rate of evaporated cryogen83 exiting pressure relief valve 82. The audible indication may be inthe form of a whistle where the pitch or volume of the whistle mayincrease as the flow rate of evaporated cryogen 83 increases. Theaudible signal may provide the user with an indication of tissuefreezing effectiveness, or an indication of device failure, such as acryo balloon 62 failure.

FIG. 8 is a cross sectional schematic illustration of the distal end oflateral optical imaging probe 64. Lateral optical imaging probe 64comprises imaging probe sheath 93, fiber bundle 100 comprising centralcoherent fiber bundle 94 and outer non-coherent fiber bundle 95, andimaging element 96 comprising objective lens 97, lateral reflectivesurface 98, and imaging window 99. Imaging probe sheath 93 housesoptical fiber bundle 100, and is used to mount imaging element 96 at thedistal end of lateral optical imaging probe 64. Imaging probe sheath 93may fabricated from a thin walled polyimide tubing. The outer diameterof optical imaging sheath 92 is between approximately 0.8 mm and 1.5 mmin diameter, with a length suitable to the particular IGCB probe, whichmay vary based on specific surgical requirements. Imaging element 98 ismachined from optical grade glass forming objective lens 97, lateralreflecting surface 98 and optical imaging window 99. Objective lens 97creates an image of the anatomical surroundings within field of view 71on the surface of coherent optical bundle 94. A camera within imagingmodule 88 at the proximal end of lateral optical imaging probe 64converts the image to video image for surgical guidance. Non-coherentfiber optical bundle 95 transmits light from a light source withinproximal imaging module 88 to illuminate field of vision 71. Lateralreflecting surface 98 may be a mirror coated surface, or may function asa prism. Those skilled in the art of fiber scopes, and opticalengineering are familiar with means for designing and developing alateral optical imaging as disclosed here within, and remain within thescope of this invention, therefore, no further description is warranted.

FIGS. 9A, 9B, and 9C are schematic illustrations of the distal end ofImage Guided Cryo Balloon (IGCB) probe 101, which is an alternativeembodiment to IGCB probe 60. IGCB probe 101 comprises probe shaft 102,outer balloon 103, distal tip 104, inner cryo balloon 105, inner thermalinsulation balloon 106, cryogen balloon tube 107, insulation balloontube 109, lateral optical imaging probe 64, with lateral field of view71, and cryogen vent tube 108, and proximal terminal 109, which will bedescribed in detail below.

FIG. 9A shows the distal end of IGCB probe 101, with outer balloon 103inflated, and lateral optical imaging probe 64 imaging the surroundinganatomy from within outer balloon 103, as represented by field of view71. The proximal end of outer balloon 103 is bonded to the distal end ofprobe shaft 102, and the distal end of outer balloon 103 is bonded tothe proximal end of distal tip 104. FIG. 9B shows the distal end of IGCBprobe 101 with outer balloon 103 hidden, revealing inner cryo balloon105 in a deflated configuration, inner thermal insulation balloon 106 ina deflated configuration, with cryo balloon tube 107, and innerinsulation balloon tube 109 mounted between distal tip 104 and probeshaft 102. Also depicted is lateral optical imaging probe 64 with fieldof view 71. FIG. 9C is a cross sectional view of the distal end of IGCBprobe 101 taken at section marks B-B in FIG. 9A. Cryogen nozzle array111 is directs and meters liquid cryogen into inner cryogen balloon 105.Cryo nozzle array 111 is an array of small fenestrations in the wall ofcryogen balloon tube 107, and are between 50 and 150 microns indiameter, and number between one and approximately 20, all locatedwithin the interior of inner cryo balloon 105. Vent ports 112 arefenestrations in the wall of inner insulation balloon tube 109 andprovide fluidic communication between the inner lumen of innerinsulation balloon tube 109 and the interior of inner thermal insulationballoon 106. Inner cryo balloon 105, and inner thermal insulationballoon 106 are substantially elastic balloon, and are preferably madefrom a silicone rubber. Outer balloon 103 is substantially non-elastic,and is optically clear, and is preferably made from PET. The distal endof outer balloon 103 is bonded to the proximal end of distal tip 104using adhesive 113. The proximal end of outer balloon 103 is bonded tothe distal end of probe shaft 102 using an adhesive 113. The distal endof cryo balloon 105 is bonded to the distal end of cryogen balloon tube107, just proximal to distal tip 104 using adhesive 113. The proximalend of inner cryo balloon 105 is bonded to the distal end cryogen venttube 108 using adhesive 113 as shown. the distal end of inner thermalinsulation balloon is bonded to the distal end of inner insulationballoon tube at its distal end just proximal to distal tip 104 usingadhesive 113 as shown. The proximal end of inner insulation balloon 106is bonded to inner insulation balloon tube 109 just distal to probeshaft 101 using adhesive 113 as shown. Adhesive 113 may be any suitableadhesive. Outer balloon 103 has a burst strength between approximately 4and 12 atmospheres of pressure. Inner cryo balloon 105, and innerthermal insulation balloon 106 have a burst strength of approximately 2atmospheres of pressure or less. Cryo vent tube 108 and inner insulationballoon tube 109 are in fluidic communication at proximal terminal 110.When liquid cryogen is introduced into inner cryo balloon 105 throughcryogen nozzle array 111, inner cryo balloon 105, and inner thermalinsulation balloon 106 are pressurized due to the evaporation of cryogencausing both inner cryo balloon 105, and inner thermal insulationballoon 106 to be inflated and to conform to the inner surface of outerballoon 103. The pressure of inflation is controlled by a pressurerelief valve in proximal terminal 110, and is described in furtherdetail below. Outer balloon 103 may be inflated or deflatedindependently of of the introduction of cryogenic liquid into inner cryoballoon 105. The outer diameter of outer balloon 103 is betweenapproximately 6 mm and 20 mm or more. The length of outer balloon 103 isbetween 1 cm and 6 cm or more. The dimensions of inner cryo balloon 105and inner thermal insulation balloon 106 are sized so that both balloonsare in conformity with the interior outer balloon 103 when pressurized.Inner cryo balloon 105 is configured to freeze tissue laterally in aradial segment of outer balloon 103 between approximately 90 and 270degrees. Inner insulation balloon 106 is configured to prevent tissuefreezing in a radial segment of outer balloon 103 between approximately90 and 270 degrees. The radial segments of tissue freezing and tissueinsulation may manipulated by the dimensions of inner cryo balloon 105and inner thermal insulation balloon 106, and manipulation of theirmaterial properties, including elasticity. Lateral optical probe 64 maybe inserted into and withdrawn from outer balloon 103, prior to acryosurgical step, and after a cryosurgical step.

FIG. 10 is a cross section Illustration of IGCB probe 101 taken atsection C-C of FIG. 9C. Probe shaft 102 may me substantially rigid andextruded of a surgical metal, or may be substantially flexible andextruded from a plastic material such as urethane, PeBax®, nylon orpolyethylene. The diameter of probe shaft 102 is between approximately2.5 and 3.5 mm. The length of probe shaft 102 is application specificand may range between 10 cm and 100 cm or more. Probe shaft 102comprises outer balloon lumen 114, inner thermal insulation balloonlumen 115, imaging probe lumen 116, and inner cryo balloon lumen 117.Inner insulation balloon tube 109 resides within inner thermalinsulation balloon lumen 115 for at least a portion of the length ofprobe shaft 102. Inner insulation balloon tube 109 may be bonded withininner thermal insulation balloon lumen 115 with an adhesive. Lateraloptical imaging probe 64 is configured to reside within optical imaginglumen 116, and may be inserted and withdrawn form optical imaging lumen116 from a port in proximal terminal 110, which will be described infurther detail below. Cryo tube 107 resides within cryo vent tube 108 ina coaxial relationship as shown. Cryo vent tube 108 resides within innercryo balloon lumen 117 as shown. Inner cryo balloon tube 105, and innerthermal insulation balloon tube 109 may be fabricated from a stainlesssteel of Nitinol® hypodermic tube. Cryo vent tube 108 may be fabricatedfrom a plastic extrusion, or a metal hypodermic tube. The inner crosssectional area of inner cryo balloon tube 107 is approximately less thanone half of the inner cross sectional area of cryo vent tube 108.

FIG. 11 is a cross section schematic illustration of the distal end ofIGCB probe 101 during a cryosurgical step. Lateral optical imaging probe64 has been withdrawn from the interior of outer balloon 103. Liquidcryogen 119 is shown being sprayed at the lateral wall of inner cryoballoon 105. As a result of the evaporation of liquid cryogen 119 innercryo balloon 105, and inner insulation balloon 106 are inflated at apressure controlled by a pressure relief valve in the proximal terminal110 by evaporated cryogen gas 120, into substantial conformance to theinner surface of outer balloon 103. Ice ball 118 is formed within thetissue adjacent to inner cryo balloon 105. Tissue adjacent to innerthermal insulation balloon 106 is spared from freezing, and thereforefreezing injury.

FIG. 12 is a transverse cross sectional schematic illustration of IGCBprobe 101 taken at section D-D of FIG. 11 . Depicted is liquid cryogen119 being sprayed at the inner wall of inner cryo balloon 105 bycryogenic nozzle array in inner cryo balloon tube 107. As a result,liquid cryogen 119 evaporates at the surface of inner cryo balloon 107forming cryogenic gas 120, that is maintained at a pressure sufficientto inflate inner cryo balloon 105 and inner thermal insulation balloon106 into conformance with the interior of outer balloon 103 as show.

FIG. 13 is a schematic illustration of proximal terminal 110 of IGCBprobe 101. Hub 121 fluidically connects outer balloon lumen 114 to outerballoon lumen hub tube 122, inner cryo balloon tube 107 to cryo balloonhub tube 123, and provides an insertion path for optical probe 64 intooptical probe lumen 116 though optical probe port 86 and optical probehub tube 125. Hub 121 is also configured to provide fluidiccommunication between inner cryo balloon lumen 117, inner cryo balloonvent tube 108, and inner thermal insulation balloon tube 109, and hubcryo exhaust tube 126. Hub 121 may be insert molded using mandrels tocreate discrete channels between the hub tubes and lumens describedabove. Those skilled in the art of surgical probe hub design andmanufacture are familiar methods for designing and manufacturing the anIGCB probe hub as disclosed here within, therefore no furtherdescription is warranted. Imaging probe port 124 may comprise a ToughyBorst connector, or another type of surgical pressure port. Imagingmodule 88 comprises a camera and a light source, and has been previouslydescribed in detail. Inner cryo balloon tube 107 is connected to asource of liquid cryogen 90 by means of cryogen port 127, cryogen sourcehose 91, and cryogen connector 92. Liquid cryogen source 90 is depictedschematically as a cryogen tank. The liquid cryogen source may comprisea control console that controls the flow of cryogen based on usersettings, and feedback from sensors, not shown. The liquid cryogen maybe liquid carbon dioxide or liquid nitrogen, or a liquidchlorofluorocarbon compound. Alternatively, instead of using evaporativecooling, a Joules-Thompson effect (adiabatic gas expansion) coolingarchitecture could employed and still be within the scope of thisinvention. Nitrous oxide or argon gas would be the preferred cryogenicgasses for use if a Joule-Thompson cooling architecture is employed.Those skilled in the art cryosurgical probe design and manufacture arefamiliar the design attributes and trade-offs between liquid cryogenevaporative cooling and Joule-Thompson effect cooling architectures, andare familiar with the means for employing either cooling architecturewithin the scope of this invention, therefore no further discussion iswarranted. Outer balloon lumen 114 is in fluidic communication withballoon lumen hub tube 122. Syringe 128 provides the user a means toeither inflate outer balloon 103 prior to or after a cryosurgical step.Pressure relief valve 129 vents evaporated cryogen 120 to the ambientatmosphere while maintaining a set pressure within inner cryo balloon105 and inner thermal insulation balloon 106 during liquid cryogendelivery. The pressure created by pressure relief valve 129 is used tomaintain inflation of inner cryo balloon 105 and inner thermalinsulation balloon 106 in order to maintain their conformity with theinterior surface of outer balloon 103. Pressure relief valve 129 mayhave a fixed preset pressure relief setting, or pressure relief valve129 may have a user adjustable pressure setting within a range ofpressures that are lower than the burst strength of outer balloon 103.Pressure relief valve 129 may also comprise an audible indication of thevolumetric flow rate of evaporated cryogen 120 exiting pressure reliefvalve 129. The audible indication may be in the form of a whistle wherethe pitch or volume of the whistle may increase as the flow rate ofevaporated cryogen 120 increases. The audible signal may provide theuser with an indication of tissue freezing effectiveness, or anindication of device failure, such as an inner cryo balloon 105 failure.

FIG. 14 is cross sectional schematic illustration of a cryo-ablation ofthe function of nerve 130 using IGCB probe 101. As shown, IGCB probe 101is positioned with balloon 103 inflated and separating nerve 130 fromassociated vein 131 and artery 132. Inner cryo balloon 105 is positionedadjacent to nerve 130. Liquid cryogen 119 is being sprayed against theinner wall of inner cryo balloon 105, resulting in ice ball 118 formingin adjacent tissue and encompassing nerve 130. Inner cryo balloon 105and inner thermal insulation balloon 106 are inflated by evaporatedcryogen gas 120 as previously described. Inner thermal insulationballoon 106 is adjacent to vein 131, and artery 132 providing protectivethermal insulation from cryogenic injury.

The applications of the disclosed invention discussed above are notlimited to certain treatments or regions of the body, but may includeany number of other treatments and areas of the body. Modifications ofthe above-described methods and devices for carrying out the invention,and variations of aspects of the invention that are obvious to those ofskill in the arts are intended to be within the scope of thisdisclosure. Moreover, various combinations of aspects between examplesare also contemplated and are considered to be within the scope of thisdisclosure as well.

What is claimed is:
 1. A cryosurgical probe, comprising: an elongatedstructure with a proximal end and a distal end; a cryo-ablation elementdisposed at the distal end of the elongated structure, wherein thecryo-ablation element includes an inflatable balloon structure and aninsulation balloon, and the inflatable balloon structure includes atissue freezing zone configured to cryogenically ablate a tissue region;an optical imaging device disposed within an interior of the inflatableballoon structure of the cryo-ablation element, wherein to position thetissue freezing zone at a tissue region, a wall of the inflatableballoon structure is configured to allow the optical imaging device toimage the tissue region while the optical imaging device is disposedwithin the interior of the inflatable balloon structure; and a supplymechanism configured to introduce a cryogen into the inflatable balloonstructure and to deliver the cryogen to the tissue freezing zone,wherein the insulation balloon limits cryo-ablation, via the tissuefreezing zone, to the tissue region, while preventing cryo-ablation ofanother tissue region, wherein the insulation balloon is disposed withinthe inflatable balloon structure and configured to prevent cryo-ablationalong a radial segment of the inflatable balloon structure.
 2. Thecryosurgical probe of claim 1, wherein the optical imaging device isdisposed within the interior of the inflatable balloon structure whenthe supply mechanism introduces the cryogen into the inflatable balloonstructure and delivers the cryogen to the tissue freezing zone.
 3. Thecryosurgical probe of claim 1, wherein the inflatable balloon structurecomprises an optical imaging window, and the optical imaging deviceimages the tissue region through the optical imaging window.
 4. Thecryosurgical probe of claim 1, wherein the inflatable balloon structureis configured to dilate tissue surrounding the tissue region prior tothe supply mechanism introducing the cryogen into the inflatable balloonstructure and delivering the cryogen to the tissue freezing zone.
 5. Thecryosurgical probe of claim 1, wherein the supply mechanism isconfigured to introduce a liquid cryogen into the inflatable balloonstructure from a cryogenic fluid source fluidly coupled to theinflatable balloon structure such that the inflatable balloon structureis inflated from a deflated configuration to an expanded configurationwhile the optical imaging device is positioned within the inflatableballoon structure.
 6. The cryosurgical probe of claim 5, wherein thesupply mechanism introduces the liquid cryogen into the inflatableballoon structure by spraying the liquid cryogen from an array ofcryogen nozzles towards an inner wall of the inflatable balloonstructure corresponding to the tissue freezing zone so as to evaporatethe liquid cryogen in the inflatable balloon structure, and wherein theinflatable balloon structure is inflated as a result of evaporation ofthe liquid cryogen within the interior of the inflatable balloonstructure.
 7. The cryosurgical probe of claim 6, wherein the inflatableballoon structure is configured to be deflated by venting the evaporatedliquid refrigerant from the inflatable balloon structure using a secondlumen.
 8. The cryosurgical probe of claim 7, wherein the elongatedstructure includes a first lumen and the second lumen extending in theelongated structure between the proximal end and the distal end of theelongated structure, wherein introducing the liquid refrigerant into theinflatable balloon structure comprises supplying the liquid refrigerantto the inflatable balloon structure using the first lumen, and whereindeflating the inflatable balloon structure comprises venting theevaporated liquid refrigerant from the inflatable balloon structureusing the second lumen.
 9. The cryosurgical probe of claim 8, whereinthe first lumen and the second lumen are coaxial with each other. 10.The cryosurgical probe of claim 1, wherein the optical imaging device isconfigured to rotate around a longitudinal axis of the cryo-ablationelement while positioned within the cryo-ablation element.
 11. Thecryosurgical probe of claim 1, wherein the optical imaging device isconfigured to translate along a longitudinal axis of the cryo-ablationelement while positioned within the cryo-ablation element.
 12. Thecryosurgical probe of claim 1, wherein the optical imaging devicecomprises an imaging element coupled to a fiber bundle, the fiber bundlecoupled to an imaging module including a camera or a video display atthe proximal end of the elongated structure.
 13. The cryosurgical probeof claim 12, wherein the fiber bundle comprises an optical fiber bundlecoupled to the camera and an illuminating fiber bundle coupled to alight source of the imaging module and configured to illuminate a fieldof vision of the imaging element.
 14. The cryosurgical probe of claim13, wherein the optical fiber bundle comprises a central coherent fiberbundle and the illuminating fiber bundle comprises an outer non-coherentfiber bundle.
 15. The cryosurgical probe of claim 1, wherein thecryo-ablation element has a longitudinal axis extending between ends ofthe cryo-ablation element, and the optical imaging device has a field ofview that is in a lateral direction that is transverse to thelongitudinal axis.
 16. The cryosurgical probe of claim 15, wherein theoptical imaging device comprises a reflective surface that directs lightreceived from the lateral direction to a direction parallel to thelongitudinal axis.
 17. The cryosurgical probe of claim 1, wherein theoptical imaging device is configured to be withdrawn out of thecryo-ablation element.
 18. The cryosurgical probe of claim 1, whereinthe cryo-ablation element further includes an inner cryo balloondisposed with the insulation balloon in the inflatable balloonstructure, wherein the inner cryo balloon is configured to receive thecryogen to produce the tissue freezing zone.
 19. The cryosurgical probeof claim 18, wherein the inner cryo balloon and the insulation balloonare configured to be inflated and conform to an inner surface of theinflatable balloon structure.